Knee Arthritis, Osteoarthritis study: Knee sleeve
Official title Daily Knee Sleeve Use Versus No Use in Older Adults With Chronic Knee Pain
ClinicalTrials.gov ID: NCT07674901
What this study is testing
- What it's testing
- The study wants to see whether daily use of a knee sleeve reduces the worsening of knee arthritis seen on X‑rays over five years and improves pain, function, and quality of life.
- Who it's for
- Adults aged 50 to 64 who have knee pain lasting at least three months.
- What's involved
- Participants are randomly assigned to wear an elastic knee sleeve every day or not wear one. They will get knee X‑rays at the start and after five years, and fill out a knee‑pain questionnaire at three months and each year.
- Time commitment
- The study lasts five years, with X‑ray visits at the start and end and yearly questionnaires, plus a questionnaire at three months.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 64
You may be able to join if
- Aged 50-64 years at the time of his/her baseline eligibility screening
- Unilateral or bilateral chronic (≥ 3 months) knee pain
- Knee circumference between 12" (30 cm) and 22" (56 cm) measured over center of kneecap
- English-speaking and able to provide informed consent for study participation
You likely can't join if
- History of knee replacement surgery in the painful/affected knee(s)
- Knee replacement surgery or arthroscopic procedure scheduled or anticipated in the affected knee(s) within 1 year after study eligibility screening
- Self-reported history or medical documentation of rheumatoid arthritis, psoriatic arthritis or other inflammatory arthritis in any joint
- History of unprovoked falls
- Current use of a rigid or hinged knee brace made of metal, plastic or fiberglass, or prescription for a knee brace for the affected knee(s)
- Previous use of a knee sleeve/fabric knee support on the affected knee(s) for over 6 months cumulative time
See the full eligibility criteria
- Aged 50-64 years at the time of his/her baseline eligibility screening
- Unilateral or bilateral chronic (≥ 3 months) knee pain
- Knee circumference between 12" (30 cm) and 22" (56 cm) measured over center of kneecap; or if a larger size is needed, thigh circumference up to 28" (71 cm) measured at 4" ABOVE center of knee cap per manufacturers'...
- English-speaking and able to provide informed consent for study participation
- History of knee replacement surgery in the painful/affected knee(s)
- Knee replacement surgery or arthroscopic procedure scheduled or anticipated in the affected knee(s) within 1 year after study eligibility screening
- Self-reported history or medical documentation of rheumatoid arthritis, psoriatic arthritis or other inflammatory arthritis in any joint; peripheral arterial disease or other vascular or circulatory disorder
- History of unprovoked falls
- Current use of a rigid or hinged knee brace made of metal, plastic or fiberglass, or prescription for a knee brace for the affected knee(s)
- Previous use of a knee sleeve/fabric knee support on the affected knee(s) for over 6 months cumulative time
- Inability to pull on or remove elasticized knee sleeve from affected knee(s)
- Kellgren-Lawrence (KL) grade 4 on a baseline standing/weightbearing A/P knee radiograph of the affected knee(s) is excluded because it is the highest KL grade, so a primary outcome event (transition to a higher grade)...
- Moderate to severe knee effusion on baseline radiographs of the painful knee(s) is excluded due to the potential risk of harm and discomfort from the compressive effect of a knee sleeve.
- Pregnancy (because of x-ray exposure)
- Cannot attend a 5-year study assessment for follow-up knee radiographs
- Investigator discretion
The study team makes the final eligibility decision.
Where it is enrolling
- Springfield, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Springfield, Massachusetts, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.